CSOs Soon Put to the Test by Overseas FDA Office

Our global society and the increasing popularity of virtual companies and outsourcing, has created a host of regulatory problems for consumers and agencies of importing countries. For example, since late in 2007, the US FDA has been working to address obvious shortcomings in it's overseas inspection system, the main one being simply a lack of frequency in that a scant few facilities are actually inspected overseas each year, despite a large proportion of raw materials for American pharmaceuticals being produced overseas.

According to ICIS, more than 60% of active ingredients are being produced overseas, mainly in India and China. The much lower stringency for quality management means higher potential for errors to occur, such as the contamination of Heparin discovered this year. The anticoagulating drug was subject to extensive recalls after reports of severe allergic reactions to the contaminated product began to pour in. The FDA admitted to insufficient inspection of an American-owned production facility in China, prior to approving the drug for market. Over the counter drugs are a greater risk because they are less highly regulated, creating an unfair competitive advantage for overseas producers of generic drugs, whose risks of liability are reduced while they can cut corners and manufacture in an environment of reduced inspection frequency.

Part of the proposed solution to inspection deficiencies has been to open overseas offices and increase the frequency of inspections, with the cooperation of governing bodies in the foreign countries involved. By October 2008, a permanent FDA office is scheduled to open in China and pharmaceutical manufacturers there will be subjected to much stricter scrutiny. For the consumer, one can only hope this makes a difference and saves lives! If you're a CSO involved in manufacturing…are you ready?

_Sources:

Harris, G. and Bogdanich, W. Drug Tied to China Had Contaminant, F.D.A. Says. The New York Times, March 6, 2008.

Challener, C. Overseas Inspections Strain FDA Resources. ICIS Chemical Business, January 28, 2008.